Topical Tranexamic Acid After Intravitreal Injections

NCT ID: NCT04400916

Last Updated: 2020-05-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-30

Study Completion Date

2021-12-31

Brief Summary

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We aim to investigate whether topical administration of Tranexamic acid can reduce the occurence of subconjunctival hemorrahge after routine intravitreal injections for retinal conditions.

Detailed Description

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Conditions

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Subconjunctival Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Topical tranexamic acid

Group Type EXPERIMENTAL

Tranexamic acid

Intervention Type DRUG

A single drop administered topically

Topical BSS

Group Type PLACEBO_COMPARATOR

Balanced Salt Solution

Intervention Type OTHER

A single drop administered topically

Interventions

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Tranexamic acid

A single drop administered topically

Intervention Type DRUG

Balanced Salt Solution

A single drop administered topically

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Subjects receiving intravitreal injections as part of their routine ophthalmological care

Exclusion Criteria

Pregnancy, Oral contraceptives/HRT use, Known systemic autoimmune disease, Renal failure, active/suspected infection or inflammation in the treated eye, subconjunctival hemorrahge prior to inclusion, History of subarachnoid hemorrahge, thromboembolic events, increased risk for thromboembolic events, known sensitivity to the study drug
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Rambam Health Care Campus

OTHER

Sponsor Role lead

Responsible Party

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Shiri Soudry MD

Attending faculty and vitreoretinal surgeon, Department of Ophthalmology

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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0424-19-RMB

Identifier Type: -

Identifier Source: org_study_id

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